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This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lira 1.8 | Experimental | Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
|
| Glimepiride | Active Comparator | Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Stepwise dose increase, s.c. (under the skin) injection, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) | Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute. | week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF) | Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute. | week 0, week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23010561 | Result | Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23. | |
| 25212693 | Result | Nandy D, Johnson C, Basu R, Joyner M, Brett J, Svendsen CB, Basu A. The effect of liraglutide on endothelial function in patients with type 2 diabetes. Diab Vasc Dis Res. 2014 Nov;11(6):419-30. doi: 10.1177/1479164114547358. Epub 2014 Sep 11. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted at one site in the United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lira 1.8 | Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
| FG001 | Placebo | Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
| FG002 | Glimepiride | Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Lira 1.8 | Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
| BG001 | Placebo | Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) | Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute. | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mL/100 mL/min | week 0, week 12 |
|
The adverse events were collected from week 0 to week 12.
The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lira 1.8 | Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| placebo |
| Drug |
Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily |
|
| glimepiride | Drug | Tablets, 1 - 4 mg daily |
|
| Change in HbA1c (Glycosylated Haemoglobin A1c) |
Percentage point change in HbA1c |
| week 0, week 12 |
| Change in Fasting Plasma Glucose (FPG) | Change in FPG | week 0, week 12 |
| Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles | The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime. | week 0, week 12 |
| Change in Body Weight | week 0, week 12 |
| Fasting Lipid Profile - Change in Total Cholesterol (TC) | Change in TC | week 0, week 12 |
| Fasting Lipid Profile - Change in LDL-C | Change in LDL-C | week 0, week 12 |
| Fasting Lipid Profile - Change in HDL-C | Change in HDL-C | week 0, week 12 |
| Fasting Lipid Profile - Change in Triglycerides (TG) | Change in TG | week 0, week 12 |
| Biomarkers of Cardiovascular Risk - Change in TNF-alpha | Change in TNF-alpha | week 0, week 12 |
| Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range | Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL). | week 0, week 12 |
| Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range | Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL). | week 0, week 12 |
| Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. | weeks 0-12 |
| 25504028 | Result | Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. |
| Withdrawal by Subject |
|
| BG002 | Glimepiride | Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Previous Anti-diabetic Treatment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Glycosylated Haemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of total haemoglobin |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Total Cholesterol (TC) | Mean | Standard Deviation | mg/dL |
|
| Low density lipoprotein (LDL-C) | Mean | Standard Deviation | mg/dL |
|
| High density lipoprotein (HDL-C) | Mean | Standard Deviation | mg/dL |
|
| Triglycerides (TG) | Mean | Standard Deviation | mg/dL |
|
| Tumor necrosis factor-alpha (TNF-alpha) | Mean | Standard Deviation | pg/mL |
|
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) |
| OG002 | Glimepiride | Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12 |
|
|
|
| Secondary | Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF) | Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute. | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mL/100 mL/min | week 0, week 12 |
|
|
|
|
| Secondary | Change in HbA1c (Glycosylated Haemoglobin A1c) | Percentage point change in HbA1c | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | percentage of total haemoglobin | week 0, week 12 |
|
|
|
|
| Secondary | Change in Fasting Plasma Glucose (FPG) | Change in FPG | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mg/dL | week 0, week 12 |
|
|
|
|
| Secondary | Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles | The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime. | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mg/dL | week 0, week 12 |
|
|
|
|
| Secondary | Change in Body Weight | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | kg | week 0, week 12 |
|
|
|
|
| Secondary | Fasting Lipid Profile - Change in Total Cholesterol (TC) | Change in TC | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mg/dL | week 0, week 12 |
|
|
|
|
| Secondary | Fasting Lipid Profile - Change in LDL-C | Change in LDL-C | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mg/dL | week 0, week 12 |
|
|
|
|
| Secondary | Fasting Lipid Profile - Change in HDL-C | Change in HDL-C | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mg/dL | week 0, week 12 |
|
|
|
|
| Secondary | Fasting Lipid Profile - Change in Triglycerides (TG) | Change in TG | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | mg/dL | week 0, week 12 |
|
|
|
|
| Secondary | Biomarkers of Cardiovascular Risk - Change in TNF-alpha | Change in TNF-alpha | The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial. | Posted | Least Squares Mean | Standard Error | pg/mL | week 0, week 12 |
|
|
|
|
| Secondary | Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range | Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL). | Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure. | Posted | Number | participants | week 0, week 12 |
|
|
|
| Secondary | Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range | Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL). | Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure. | Posted | Number | participants | week 0, week 12 |
|
|
|
| Secondary | Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. | Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure. | Posted | Number | episodes | weeks 0-12 |
|
|
|
| 0 |
| 16 |
| 11 |
| 16 |
| EG001 | Placebo | Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) | 1 | 16 | 9 | 16 |
| EG002 | Glimepiride | Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12 | 0 | 17 | 5 | 17 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Parotid Duct Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Catheter Site Haematoma | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Back Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle Disorder | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Novo Nordisk reserves the right to not release data until specified milestones (e.g. when clinical trial report is available), including right to not release interim results because such action can invalidate results of the entire trial. At trial end, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate. |
| ANCOVA |
| 0.8518 |
2-sided significance level of 5%. |
| Least squares mean |
| 0.709 |
| 95 |
| -6.904 |
| 8.322 |
| Superiority or Other |
| Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate. | ANCOVA | 0.3435 | 2-sided significance level of 5%. | Least squares mean | 3.79 | 95 | -4.194 | 11.774 | Superiority or Other |
Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. |
| ANCOVA |
| 0.6207 |
2-sided significance level of 5%. |
| Least squares mean |
| -0.077 |
| 95 |
| -0.391 |
| 0.236 |
| Superiority or Other |
| Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | ANCOVA | 0.0098 | 2-sided significance level of 5%. | Least squares mean | -0.458 | 95 | -0.8 | -0.116 | Superiority or Other |
Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate. |
| ANCOVA |
| 0.0677 |
2-sided significance level of 5%. |
| Least squares mean |
| -9.653 |
| 95 |
| -20.041 |
| 0.736 |
| Superiority or Other |
| Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate. | ANCOVA | 2-sided significance level of 5%. | Least squares mean | -25.952 | 95 | -37.429 | -14.475 | Superiority or Other |
Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate. |
| ANCOVA |
| 0.7622 |
2-sided significance level of 5% |
| Least squares mean |
| 3.815 |
| 95 |
| -21.618 |
| 29.247 |
| Superiority or Other |
| Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate. | ANCOVA | 0.2651 | 2-sided significance level of 5%. | Least squares mean | -15.686 | 95 | -43.838 | 12.466 | Superiority or Other |
Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate. |
| ANCOVA |
2-sided significance level of 5%. |
| Least squares mean |
| -2.859 |
| 95 |
| -4.139 |
| -1.579 |
| Superiority or Other |
| Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate. | ANCOVA | 0.0486 | 2-sided significance level of 5%. | Least squares mean | 1.331 | 95 | 0.0090 | 2.653 | Superiority or Other |
Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate. |
| ANCOVA |
| 0.7993 |
2-sided significance level of 5%. |
| Least squares mean |
| 1.912 |
| 95 |
| -13.168 |
| 16.991 |
| Superiority or Other |
| Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate. | ANCOVA | 0.5903 | 2-sided significance level of 5%. | Least squares mean | -4.149 | 95 | -19.582 | 11.284 | Superiority or Other |
Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate. |
| ANCOVA |
| 0.6517 |
2-sided significance level of 5%. |
| Least squares mean |
| 2.773 |
| 95 |
| -9.537 |
| 15.082 |
| Superiority or Other |
| Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate. | ANCOVA | 0.8822 | 2-sided significance level of 5%. | Least squares mean | 0.929 | 95 | -11.646 | 13.505 | Superiority or Other |
Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate. |
| ANCOVA |
| 0.6362 |
2-sided significance level of 5%. |
| Least squares mean |
| -0.723 |
| 95 |
| -3.785 |
| 2.339 |
| Superiority or Other |
| Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate. | ANCOVA | 0.7283 | 2-sided significance level of 5%. | Least squares mean | 0.554 | 95 | -2.643 | 3.751 | Superiority or Other |
Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate. |
| ANCOVA |
| 0.844 |
2-sided significance level of 5%. |
| Least squares mean |
| -3.786 |
| 95 |
| -42.373 |
| 34.801 |
| Superiority or Other |
| Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate. | ANCOVA | 0.0994 | 2-sided significance level of 5%. | Least squares mean | -32.923 | 95 | -72.353 | 6.507 | Superiority or Other |
Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate. |
| ANCOVA |
| 0.9569 |
2-sided significance level of 5%. |
| Least squares mean |
| -0.018 |
| 95 |
| -0.697 |
| 0.661 |
| Superiority or Other |
| Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate. | ANCOVA | 0.2465 | 2-sided significance level of 5%. | Least squares mean | -0.402 | 95 | -1.097 | 0.293 | Superiority or Other |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Symptoms Only |
|